FDA 510(k) Application Details - K972781

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K972781
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	PRISM THERAPEUTICS, LLC. 11504 RIVEREDGE RD. DOSWELL, VA 23047 US Other 510(k) Applications for this Company
Contact	MARK LICATA Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/1997
Decision Date	09/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review